Clinical Research Assistant

InSync Consulting is seeking a highly skilled professional to independently monitor Phase I and Phase II clinical trials, ensuring compliance with study protocols, ICH‑GCP guidelines, and regulatory requirements. This is an excellent opportunity to support innovative clinical research while enjoying a flexible schedule with both onsite and remote monitoring responsibilities. What You'll D Conduct independent onsite and remote monitoring visits for Phase I and Phase II clinical trials Perform source data verification (SDV) and review source documentation for accuracy and protocol compliance Review informed consent forms, regulatory files, and study documentation Prepare monitoring visit reports, follow‑up letters, and site correspondence Resolve Electronic Data Capture (EDC) queries and ensure timely site follow‑up Partner with investigators, study coordinators, sponsors, and research teams to support successful study execution Identify protocol deviations, communicate findings, and drive resolution of action items Ensure compliance with ICH‑GCP, sponsor requirements, and applicable regulatory standards What We're Looking F Bachelor's degree in Life Sciences, Healthcare, Nursing, Public Health, or a related field Current GCP certification Minimum of 3 years of independent clinical research monitoring experience Experience monitoring Phase I and/or Phase II clinical trials Strong knowledge of ICH‑GCP, FDA regulations, and clinical trial compliance Experience with Source Data Verification (SDV), Trial Master Files (TMF), and Electronic Data Capture (EDC) system Excellent written communication skills with experience preparing monitoring reports Ability to independently manage monitoring activities with minimal supervision Preferred Qualificati Neuroscience or neurology clinical research experience Imaging research experience (MRI, PET, CT, or related studies) ACRP, CCRP, SOCRA, or equivalent certification Schedule & Tr Approximately 8–10 monitoring visits per quarter Onsite visits in New Haven, CT typically last 6–8 hours Remote monitoring activities typically last 4–6 hours Flexible scheduling with advance notice for onsite visits #J-18808-Ljbffr